Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection

In brief

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

Key facts

Study ID

NCT01314261

Run by

AbbVie (prior sponsor, Abbott)

People needed

37

Starts

2011-03-01

Expected to finish

2013-02-01

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment naïve participants
• Females must be either postmenopausal for at least 2 years or surgically sterile
• Males must be surgically sterile or practicing specific forms of birth control
• Chronic hepatitis C virus (HCV), genotype-1 infected participants
• Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis

You may not qualify if…

• Pregnant or breastfeeding female
• Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
• Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
• Current or past clinical evidence of cirrhosis or bridging fibrosis
• Abnormal screening laboratory results

Where it is running

• Site Reference ID/Investigator# 56623 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 48476 — Los Angeles, California, United States
• Site Reference ID/Investigator# 51345 — Orlando, Florida, United States
• Site Reference ID/Investigator# 51498 — Honolulu, Hawaii, United States
• Site Reference ID/Investigator# 48473 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 52782 — Kansas City, Missouri, United States
• Site Reference ID/Investigator# 48471 — Houston, Texas, United States
• Site Reference ID/Investigator# 48474 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 48477 — Fairfax, Virginia, United States
• Site Reference ID/Investigator# 48472 — Seattle, Washington, United States
• Site Reference ID/Investigator# 48483 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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